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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004519
Receipt No. R000005407
Scientific Title Fundus imaging using novel high resolution scannning LASER ophthalmoscope (SLO)
Date of disclosure of the study information 2010/12/01
Last modified on 2014/08/27

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Basic information
Public title Fundus imaging using novel high resolution scannning LASER ophthalmoscope (SLO)
Acronym Fundus imaging using novel high resolution scannning LASER ophthalmoscope (SLO)
Scientific Title Fundus imaging using novel high resolution scannning LASER ophthalmoscope (SLO)
Scientific Title:Acronym Fundus imaging using novel high resolution scannning LASER ophthalmoscope (SLO)
Region
Japan

Condition
Condition "Healthy volunteers, or patients with:
macular disease (age-related macular degeneration, macular hole, macular pucker etc.),
glaucoma,
diabetic retinopathy,
retinal vein occlusion,
adult disease"
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 "To take images of fundus oculi, and evaluate the equipment based on medical perspective.
To confirm equipment specific performance for healthy volunteers, and then assess fundus images for various cases.
To develop the hardware for improving the performance."
Basic objectives2 Others
Basic objectives -Others "To develop software analyzing fundus images of healthy volunteers and various cases to offer medical information.
For example the software analyzes photoreceptors, cpilaries and blood flows. "
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To take retinal images for healthy volunteers and patients by using the novel SLO equipment, and assess relationship between fundus images and various cases.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 To examine eligibility and take fundus images in a day.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria "1) Male or female aged 20 to 80
2) Healthy volunteers, or patients with:
macular disease (age-related macular degeneration, macular hole, macular pucker etc.),
glaucoma,
diabetic retinopathy,
retinal vein occlusion,
adult disease (hypertension, diabetes mellitus)
3) Subjects who sign an informed consent form to participate in the clinical study"
Key exclusion criteria "1) Having any side-effects (hypersensitivity, rised intraocular pressure etc.) against mydriatics
2) Revealed narrow angle by slit-lamp examination
3) Subjects who a doctor in attendance declares ineligible for any reason"
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nagahisa Yoshimura
Organization Kyoto University Graduate School of Medicine
Division name Ophthalmology & Visual Sciences
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL 075-751-3248
Email nagaeye@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sotaro Ooto
Organization Kyoto University Graduate School of Medicine
Division name Ophthalmology & Visual Sciences
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL 075-751-3248
Homepage URL
Email ohoto@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2010 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 08 Day
Last modified on
2014 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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